Phase 2
N=29
A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema
Hereditary Angioedema
Bottom Line
View on ClinicalTrials.gov: NCT05695248 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Number of Participants Experiencing Treatment-emergent Adverse Events — 4; 9; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Navenibart (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Astria Therapeutics, Inc.
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Treatment-emergent Adverse Events |
4; 9; 12 | — |
| SECONDARY Percent Change From Baseline in Monthly Hereditary Angioedema (HAE) Attack Rate |
-84.131; -85.225; -88.286 | — |
| SECONDARY Number of Participants Who Were HAE Attack Free |
1; 6; 7 | — |
| SECONDARY Severity of HAE Attacks Experienced by Participants |
1; 6; 7; 1; 1; 2 | — |
| SECONDARY Duration of HAE Attacks |
23.3; 37.1; 54.3 | — |
| SECONDARY Number of HAE Attacks Requiring On-demand Therapy |
1.0; 6.4; 3.5 | — |
| SECONDARY Time to First HAE Attack After First and Last Dosing |
109.00; 241.00; NA; 109.00; 159.00; NA | — |
| SECONDARY Proportion of HAE Attack-free Days |
0.988; 0.974; 0.984 | — |
| SECONDARY Maximum Drug Concentration (Cmax) of Navenibart |
39.170; 57.684; 119.334 | — |
| SECONDARY Percent Change From Baseline in Plasma Levels of Cleaved High-molecular-weight Kininogen (cHMWK) |
-60.702; -51.635; -74.878 | — |
| SECONDARY Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Navenibart |
2; 3; 6 | — |
Summary
The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of HAE (type I or II). The following must be met:
a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
- Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
Exclusion Criteria
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
- Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
- lanadelumab within 90 days
- berotralstat within 21 days
- all other prophylactic therapies, within 7 days
- Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening.
- Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
Data sourced from ClinicalTrials.gov (NCT05695248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.